DEVICE: Pharmaceutical Innovations (00300361600254)
Device Identifier (DI) Information
Pharmaceutical Innovations
Photon Transmitting Gel
In Commercial Distribution
36-1600-25
PHARMACEUTICAL INNOVATIONS INC
Photon Transmitting Gel
In Commercial Distribution
36-1600-25
PHARMACEUTICAL INNOVATIONS INC
Photon Transmitting Gel: 250 ml bottle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Coupling gel, non-sterile | A non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUI | Media,Coupling,Ultrasound |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
84b7bf28-109f-4b9d-8628-0367178cb5b2
March 29, 2018
2
September 14, 2016
March 29, 2018
2
September 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10300361600251 | 12 | 00300361600254 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
973-242-2900
info@pharminnovations.com
info@pharminnovations.com